CLARUS
Camera, Ophthalmic, Slit-scanning
Carl Zeiss Meditec, Inc
The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc with the FDA for Clarus.
Pre-market Notification Details
| Device ID | K191194 |
| 510k Number | K191194 |
| Device Name: | CLARUS |
| Classification | Camera, Ophthalmic, Slit-scanning |
| Applicant | Carl Zeiss Meditec, Inc 5160 Hacienda Drive Dublin, CA 94568 |
| Contact | Saurabh Jamkhindikar |
| Correspondent | Saurabh Jamkhindikar Carl Zeiss Meditec, Inc 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | QER |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2019-06-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057748096044 | K191194 | 000 |
Trademark Results [CLARUS]
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